Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population

NCT02854397 | Terminated

• 1 other identifier: 38RC15.180
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 14

Brief Summary

In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care. The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).

Conditions

Hereditary Angioedema; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• VE-cadherin level

  For the diagnosis of acute attack of hereditary angioedema

  Half a day

Secondary Outcomes (4)

• Dosage of VE-cadherin (vascular endothelial)

  Half a day

• Dosage of Fc KHPM

  Half a day

• Dosage of D-dimer

  Half a day

• Dosage of Tryptase

  Half a day

Study Arms (3)

patients with hereditary angioedema

A blood sample will be performed in crisis and 7 days after the crisis.

Other: blood sample

patients with angioedema resulting of mast cell activation

A blood sample will be performed in crisis and 7 days after the crisis.

Other: blood sample

healthy patients, without angioedema

A quantity of additional blood was taken from eligible patients who had a scheduled blood sample.

Other: blood sample

Interventions

blood sample OTHER

healthy patients, without angioedema; patients with angioedema resulting of mast cell activation; patients with hereditary angioedema

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with hereditary angioedema patients with angioedema resulting of mast cell activation healthy patients, without angioedema

You may qualify if:

• For HAE: patient with a documented diagnosis of HAE:
• HAE with normal C1-INH (ex type III) with a required mutation in FXII gene or with a typical family history of HAE diagnosed by a specialized physician belonging to CREAK network.
• For AE resulting of mast cell activation: a documented diagnosis of AE resulting of mast cell activation included:
• mastocytosis,
• chronic spontaneous urticaria,
• acute urticaria after exposure of allergen during allergy challenge tests,
• mast cell activation syndrome.
• For the control group:
• composed of patients who presented a stabilized disease (that was not infectious, not auto-inflammatory or inflammatory disease and without implication of endothelial cells).

You may not qualify if:

• Over 18 years or under 1 year.
• Diagnosis of HAE with a normal C1 esterase inhibitor or AE of unknown aetiology.
• Patients with HAE who received an acute attack treatment before the blood sample (the C1 esterase inhibitor concentrate or a bradykinin B2 receptor antagonist); patients with HAE who received a prophylactic treatment (danazol).
• Patients who were treated by omalizumab or corticosteroid treatment.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (14)

University hospital angers

Angers, 49933, France

Location

University Hospital Besançon

Besançon, 25030, France

Location

University hospital Bordeaux

Bordeaux, 33076, France

Location

University hopital Clermont-Ferrand

Clermont-Ferrand, 63503, France

Location

University Hospital Grenoble

Grenoble, 38043, France

Location

University Hospital Lille

Lille, 59037, France

Location

University Hospital Lyon

Lyon, 69677, France

Location

University hospital Marseille

Marseille, 13385, France

Location

University hospital Montpellier

Montpellier, 34295, France

Location

University hospital Nancy

Nancy, 54500, France

Location

General Hospital

Niort, 79021, France

Location

university hospital Saint-Antoine (AP-HP)

Paris, 75571, France

Location

University hospital Rouen

Rouen, 76031, France

Location

University hospital Toulouse

Toulouse, 31059, France

Location

Related Publications (39)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anne Pagnier

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: August 3, 2016
• Study Start: February 15, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

FR (14)